End Stage Kidney Disease (ESKD)MCO-HDNCT07679763
Randomized Cross-Over Comparison of Medium Cut-Off and High-Flux Hemodialysis Membranes
A study testing Medium Cut-Off Hemodialysis Membrane and High-Flux Hemodialysis Membrane in people with End Stage Kidney Disease (ESKD) and Hemodialysis, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
Patients receiving maintenance hemodialysis are at increased risk of cardiovascular disease, chronic inflammation, endothelial dysfunction, and impaired quality of life. Medium cut-Off (MCO) hemodialysis membranes have been developed to enhance the removal of middle-molecular-weight uremic toxins compared with… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- End Stage Kidney Disease (ESKD), Hemodialysis, Cardiovascular Diseases (CVD)
- What is being tested?
- Medium Cut-Off Hemodialysis Membrane and High-Flux Hemodialysis Membrane
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2026to Jan 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 80 years.
- Receiving maintenance hemodialysis for at least 6 months.
- Clinically stable and receiving thrice-weekly hemodialysis.
- Able to comply with study procedures, questionnaires, and scheduled assessments.
- Able and willing to provide written informed consent.
Who cannot join
- Acute infection at screening or enrollment.
- Major surgery within the previous 3 months.
- Active malignancy requiring ongoing treatment.
- Terminal illness with limited life expectancy.
- Physical or cognitive impairment preventing completion of study procedures or questionnaires.
- Inability or unwillingness to provide written informed consent.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi University Faculty of Medicine, Department of Nephrology, Hemodialysis Unit
Ankara, Ankara, 06500
About this study
Official title: Randomized Cross-Over Evaluation of Medium Cut-Off and High-Flux Hemodialysis Membranes on Inflammation and Cardiovascular Function in Maintenance Hemodialysis Patients
Patients receiving maintenance hemodialysis are at increased risk of cardiovascular disease, chronic inflammation, endothelial dysfunction, and impaired quality of life. Medium cut-Off (MCO) hemodialysis membranes have been developed to enhance the removal of middle-molecular-weight uremic toxins compared with conventional high-flux membranes, which may improve inflammatory status and cardiovascular health.
The aim of this study is to compare the effects of MCO and high-flux hemodialysis membranes on inflammatory biomarkers and cardiovascular function in adult patients receiving maintenance hemodialysis. The primary outcomes are changes in serum interleukin-6 (IL-6) and vascular cell adhesion molecule-1 (VCAM-1) levels. Secondary outcomes include arterial stiffness assessed by pulse wave velocity (PWV), body composition assessed by Body Composition Monitor (BCM), handgrip strength, and patient-reported outcomes including quality of life, pruritus, and pain scores.
Read more
This is a prospective, randomized, open-label, two-sequence, two-period crossover study conducted at Gazi University Faculty of Medicine. Thirty adult hemodialysis patients will be randomized to one of two treatment sequences. Participants in Sequence A will receive MCO dialysis membranes for the first 3 months followed by high-flux membranes for the next 3 months. Participants in Sequence B will receive high-flux membranes for the first 3 months followed by MCO membranes for the next 3 months. Blood samples and clinical assessments will be performed at baseline, month 3, and month 6.
The study is expected to provide evidence regarding the effects of different dialysis membrane technologies on inflammation and cardiovascular health and may contribute to optimizing membrane selection in routine hemodialysis practice.
Read the detailed description
Cardiovascular disease remains the leading cause of morbidity and mortality in patients receiving maintenance hemodialysis. Chronic inflammation, endothelial dysfunction, vascular stiffness, and the accumulation of middle-molecular-weight uremic toxins are considered important contributors to adverse cardiovascular outcomes in this population. Conventional high-flux hemodialysis membranes provide effective small-solute clearance but have limited capacity for removing larger middle molecules involved in inflammation and vascular injury.
Medium cut-off (MCO) membranes have been developed to enhance the clearance of larger middle molecules while maintaining albumin retention within acceptable limits. Previous studies have suggested that MCO membranes may improve inflammatory profiles and patient-centered outcomes; however, data regarding their effects on endothelial dysfunction, arterial stiffness, body composition, and patient-reported outcomes remain limited.
This study is designed as a prospective, randomized, open-label, two-sequence, two-period crossover clinical investigation comparing MCO and high-flux hemodialysis membranes in maintenance hemodialysis patients. Participants will be randomized in a 1:1 ratio to one of two treatment sequences. Sequence A will receive MCO membranes during Period 1 (Months 0-3) followed by high-flux membranes during Period 2 (Months 3-6). Sequence B will receive high-flux membranes during Period 1 followed by MCO membranes during Period 2. This crossover design allows each participant to serve as his or her own control, thereby reducing inter-individual variability.
Study assessments will be performed at baseline, Month 3, and Month 6. In addition to routine laboratory testing performed during standard hemodialysis follow-up, blood samples will be obtained at baseline, Month 3, and Month 6 for the measurement of serum interleukin-6 (IL-6) and vascular cell adhesion molecule-1 (VCAM-1). Cardiovascular assessment will include pulse wave velocity (PWV) measurement. Nutritional and body composition status will be evaluated using Body Composition Monitor (BCM) parameters, including overhydration, ECW/TBW ratio, intracellular water, lean tissue index, body cell mass, and phase angle. Functional status will be assessed by handgrip strength measurement. Patient-reported outcomes will be evaluated using the Kidney Disease Quality of Life-36 (KDQOL-36), UP-Dial pruritus questionnaire, and Short-Form McGill Pain Questionnaire (SF-MPQ).
The primary objective is to compare the effects of MCO and high-flux membranes on IL-6 and VCAM-1 levels. Secondary objectives include evaluation of arterial stiffness, body composition, physical function, and patient-reported outcomes. The findings may provide clinically relevant evidence regarding membrane selection strategies in routine hemodialysis practice.
- Conditions
- End Stage Kidney Disease (ESKD), Hemodialysis, Cardiovascular Diseases (CVD), Inflammation
- Being tested
- Medium Cut-Off Hemodialysis Membrane, High-Flux Hemodialysis Membrane
- Keywords
- End-Stage Kidney Disease, High-Flux Hemodialysis, Medium Cut-Off Membrane, Interleukin-6, VCAM-1, Inflammation, Cardiovascular Function, Pulse Wave Velocity, Body Composition Monitor
- Medical subject headings
- Kidney Failure, Chronic, Cardiovascular Diseases, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medium Cut-Off Hemodialysis MembraneDevice
Medium cut-off (MCO) hemodialysis membrane used as part of routine maintenance hemodialysis treatment. MCO membranes are designed to enhance the clearance of larger middle-molecular-weight uremic toxins while maintaining clinically acceptable albumin retention. Participants assigned to MCO treatment periods will receive thrice-weekly hemodialysis according to standard clinical practice. In this study, MCO treatment will be delivered using the ELISIO™ MCO series (Nipro).
High-Flux Hemodialysis MembraneDevice
High-flux hemodialysis membrane used as part of routine maintenance hemodialysis treatment. High-flux membranes represent the current standard dialysis technology and provide effective clearance of small solutes and selected middle molecules. Participants assigned to high-flux treatment periods will receive thrice-weekly hemodialysis according to standard clinical practice. In this study, high-flux treatment will be delivered using the ELISIO™ HF series (Nipro).
| Study group | Role | What they receive |
|---|---|---|
| Sequence A (MCO to High-Flux) | Experimental | Participants randomized to Sequence A will receive medium cut-off (MCO) hemodialysis membranes during Period 1 (Months 0-3), followed by high-flux hemodialysis membranes during Period 2 (Months 3-6). Hemodialysis will be performed three times weekly according to standard clinical practice. Clinical, laboratory, and patient-reported outcome assessments will be performed at baseline, Month 3, and Month 6. Receives: Device: Medium Cut-Off Hemodialysis Membrane; Device: High-Flux Hemodialysis Membrane |
| Sequence B (High-Flux to MCO) | Experimental | Participants randomized to Sequence B will receive high-flux hemodialysis membranes during Period 1 (Months 0-3), followed by medium cut-off (MCO) hemodialysis membranes during Period 2 (Months 3-6). Hemodialysis will be performed three times weekly according to standard clinical practice. Clinical, laboratory, and patient-reported outcome assessments will be performed at baseline, Month 3, and Month 6. Receives: Device: Medium Cut-Off Hemodialysis Membrane; Device: High-Flux Hemodialysis Membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Serum Interleukin-6 (IL-6)
Comparison of serum interleukin-6 (IL-6) concentrations during treatment with medium cut-off and high-flux hemodialysis membranes.
Measured: At baseline (July 2026), Month 3 (October 2026), and Month 6 (January 2027)
Change in Serum Vascular Cell Adhesion Molecule-1 (VCAM-1)
Comparison of serum vascular cell adhesion molecule-1 (VCAM-1) concentrations during treatment with medium cut-off and high-flux hemodialysis membranes.
Measured: At baseline (July 2026), Month 3 (October 2026), and Month 6 (January 2027)
Secondary outcomes (10)
Change in Pulse Wave Velocity (PWV)
Assessment of arterial stiffness by pulse wave velocity measurements.
Measured: At baseline (July 2026), Month 3 (October 2026), and Month 6 (January 2027)
Change in Handgrip Strength
Assessment of physical function using handgrip strength measurement.
Measured: At baseline (July 2026), Month 3 (October 2026), and Month 6 (January 2027)
Change in Kidney Disease Quality of Life-36 (KDQOL-36) Score
Evaluation of patient-reported quality of life using the KDQOL-36 questionnaire.
Measured: At baseline (July 2026), Month 3 (October 2026), and Month 6 (January 2027)
Change in UP-Dial Pruritus Score
Evaluation of pruritus severity using the Uraemic Pruritus in Dialysis Patients (UP-Dial) scale. The UP-Dial total score ranges from 0 to 56, with higher scores indicating more severe pruritus and a worse outcome.
Measured: At baseline (July 2026), Month 3 (October 2026), and Month 6 (January 2027)
Change in Short-Form McGill Pain Questionnaire (SF-MPQ) Score
Evaluation of pain using the Short-Form McGill Pain Questionnaire (SF-MPQ) total Pain Rating Index score. The SF-MPQ total Pain Rating Index score is calculated from 15 pain descriptors, each scored from 0 to 3, resulting in a total score range of 0 to 45. Higher scores indicate greater pain severity and a worse outcome.
Measured: At baseline (July 2026), Month 3 (October 2026), and Month 6 (January 2027)
Change in Overhydration (OH)
Assessment of overhydration (OH, L) measured using the Body Composition Monitor (BCM).
Measured: At baseline (July 2026), Month 3 (October 2026), and Month 6 (January 2027)
Change in Extracellular Water to Total Body Water Ratio (ECW/TBW)
Assessment of the extracellular water to total body water ratio (ECW/TBW) using the Body Composition Monitor (BCM).
Measured: At baseline (July 2026), Month 3 (October 2026), and Month 6 (January 2027)
Change in Intracellular Water (ICW)
Assessment of intracellular water (ICW, L) using the Body Composition Monitor (BCM).
Measured: At baseline (July 2026), Month 3 (October 2026), and Month 6 (January 2027)
Change in Lean Tissue Index (LTI)
Assessment of lean tissue index (LTI, kg/m²) using the Body Composition Monitor (BCM).
Measured: At baseline (July 2026), Month 3 (October 2026), and Month 6 (January 2027)
Change in Body Cell Mass (BCM)
Assessment of body cell mass (BCM, kg) using the Body Composition Monitor.
Measured: At baseline (July 2026), Month 3 (October 2026), and Month 6 (January 2027)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start1 Jul 2026
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for End Stage Kidney Disease (ESKD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will be randomized in a 1:1 ratio to one of two treatment sequences. Sequence A will receive medium cut-off (MCO) hemodialysis membranes during the first 3-month treatment period followed by high-flux membranes during the second 3-month treatment period. Sequence B will receive high-flux membranes during the first treatment period followed by MCO membranes during the second treatment period. Clinical and laboratory assessments will be performed at baseline, Month 3, and Month 6.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Collaborators
- Nipro Medical Corporation
- Responsible party
- Principal investigator, Veysel Baran TOMAR, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07679763
- Sponsor's protocol ID
- GAZI-HD-MCO-HF-2026
- Acronym
- MCO-HD
- Status last verified
- Sep 2026
- First submitted
- 24 Jun 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) are not planned to be shared publicly. The study involves a limited number of participants from a single center, and data will be retained and managed in accordance with institutional policies, ethical requirements, and applicable data protection regulations.
Publications
Yang J, Ke G, Liao Y, Guo Y, Gao X. Efficacy of medium cut-off dialyzers and comparison with high-flux dialyzers in patients on maintenance hemodialysis: A systematic review and meta-analysis. Ther Apher Dial. 2022 Aug;26(4):756-768. doi: 10.1111/1744-9987.13755. Epub 2021 Dec 4.
PubMed 34773675Zickler D, Schindler R, Willy K, Martus P, Pawlak M, Storr M, Hulko M, Boehler T, Glomb MA, Liehr K, Henning C, Templin M, Trojanowicz B, Ulrich C, Werner K, Fiedler R, Girndt M. Medium Cut-Off (MCO) Membranes Reduce Inflammation in Chronic Dialysis Patients-A Randomized Controlled Clinical Trial. PLoS One. 2017 Jan 13;12(1):e0169024. doi: 10.1371/journal.pone.0169024. eCollection 2017.
PubMed 28085888Kirsch AH, Lyko R, Nilsson LG, Beck W, Amdahl M, Lechner P, Schneider A, Wanner C, Rosenkranz AR, Krieter DH. Performance of hemodialysis with novel medium cut-off dialyzers. Nephrol Dial Transplant. 2017 Jan 1;32(1):165-172. doi: 10.1093/ndt/gfw310.
PubMed 27587605